社團法人臺灣臨床藥學會

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【原著】比較Febuxostat及Allopurinol在痛風併慢性腎臟病病人的有效性及安全性
Comparison of the Efficacy and Safety of Febuxostat and Allopurinol in Patients With Gout and Chronic Kidney Disease
Febuxostat,Allopurinol,慢性腎臟病,痛風、Chronic Kidney Disease, Gout
楊璦瑜Ai-Yu Yang1,* 、蘇玉惠Yu-Hui Su1 、蔡憶萱Yi-Hsuan Tsai1
1高雄醫學大學附設中和紀念醫院藥學部
目的:痛風是慢性腎臟病 (chronic kidney disease, CKD) 的常見併發症。支持febuxostat上市的大型臨床研究顯示在高尿酸血症的病人,febuxostat 比allopurinol 更有效且同樣安全。然而腎臟功能是研究限制條件之一,使用於CKD 的相關研究仍顯不足。本研究將比較febuxostat 及allopurinol 在痛風併有慢性腎臟病 ( 估算的腎小球過濾率[estimated glomerular filtration rate, eGFR] < 30 mL/min/1.73 m2) 病人的有效性及安全性。

方法:運用回顧性研究,收納使用febuxostat 或allopurinol 治療的痛風併慢性腎臟病的病人。以治療後血清尿酸值< 6 mg/dL 為治療目標。在治療12 週後比較有效性 ( 尿酸值變化 ) 及安全性 ( 肝腎功能變化、不良反應的發生 )。

結果:我們的研究收納18 位使用allopurinol 及116 位febuxostat 的病人。治療12 週後,febuxostat 組有67 人 (57.7%) 達治療目標,但allopurinol 組無人達到治療目標。兩組病人治療前後血清尿酸值下降皆達顯著差異 (p < 0.05)。安全性部分,2組病人治療前後肝腎功能無顯著差異,未發生嚴重不良反應。

結論:我們的研究顯示在痛風併慢性腎臟病病人,與allopurinol 相比febuxostat更能達到降尿酸的效果,且兩者的安全性相似。

Objective: Gout is a common complication of chronic kidney disease (CKD). Postmarketing studies indicated that febuxostat was more effective than allopurinol and shows a similar safety profile in patients with hyperuricemia. However, the role of febuxostat in patients with CKD has not been adequately investigated, which is a limitation of the aforementioned studies. We compared the efficacy and safety of febuxostat and allopurinol in patients with CKD (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2).

Methods: This retrospective study was performed in patients with gout and CKD receiving febuxostat or allopurinol therapy. The treatment goal was the changes in serum uric acid (sUA) level achieving a target of < 6 mg/dL. Therapeutic efficacy (changes in sUA values) and safety (changes in liver and kidney function and occurrence of adverse reactions) were assessed after 12 weeks.

Results: Our study included 116 patients taking febuxostat and 18 taking allopurinol. After drugs intervention, 57.7% of the patients in the febuxostat group achieved the treatment goal, but none of the allopurinol group achieved treatment goal after 12 weeks. Significant intergroup differences were observed in sUA levels (reduced levels) after treatment (p < 0.05). No significant intergroup differences were observed in liver and kidney function before and after treatment, and no serious adverse reactions occurred.

Conclusions: Our study showed that febuxostat significantly reduced the sUA and had similar safety profile in patients with gout and CKD in comparison with
allopurinol.
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